2024
Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update
Loibl S, Jassem J, Sonnenblick A, Parlier D, Winer E, Bergh J, Gelber R, Restuccia E, Im Y, Huang C, Dalenc F, Calvo I, Procter M, Caballero C, Clark E, Raimbault A, McConnell R, Monturus E, de Azambuja E, Gomez H, Bliss J, Viale G, Bines J, Piccart M, Aebi S, Andersson M, Bergh J, Bines J, Bliss J, Bonnefoi H, Caballero C, Cameron D, Cardoso F, Clark E, de Azambuja E, de Haas S, Dent S, Fein L, Frank E, Gelber R, Gnant M, Gomez Moreno H, Im S, Jackisch C, Janni W, Jassem J, Krop I, Kümmel S, Liu T, Loi S, Loibl S, Masuda N, Nili Gam-Yal E, Nyawira B, Pascual T, Piccart M, Pienkowski T, Procter M, Restuccia E, Rodríguez-Lescure Á, Suter T, Thomssen C, Tjan-Heijnen V, Tomasello G, Torres Ulloa M, Twelves C, Viale G, Walshe J, Wilcken N, Winer E. Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update. Journal Of Clinical Oncology 2024, 42: 3643-3651. PMID: 39259927, DOI: 10.1200/jco.23.02505.Peer-Reviewed Original ResearchInvasive disease-free survivalNode-negative cohortNode-positive cohortOverall survivalBreast cancerAPHINITY trialHuman epidermal growth factor receptor 2-positiveEpidermal growth factor receptor 2-positiveInvasive disease-free survival benefitHER2+) breast cancerHuman epidermal growth factor receptor 2-positive breast cancerInterim overall survival analysisYears of median follow-upIntent-to-treat populationInterim analysisHormone receptor-negativeDisease-free survivalMedian follow-upPrimary end pointOverall survival analysisAdjuvant pertuzumabAdjuvant trastuzumabReceptor-negativePlacebo groupClinical trial update
2022
Corrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Corrigendum to “Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2D metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis” [Annals of Oncology 33 (2022) 321-329]. Annals Of Oncology 2022, 34: 630. PMID: 36564285, DOI: 10.1016/j.annonc.2022.12.005.Peer-Reviewed Original Research
2021
Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Feng W, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB): final overall survival analysis. Annals Of Oncology 2021, 33: 321-329. PMID: 34954044, DOI: 10.1016/j.annonc.2021.12.005.Peer-Reviewed Original ResearchConceptsProgression-free survivalMetastatic breast cancerPlacebo-combination groupOverall survivalCombination groupBreast cancerHER2CLIMB trialBrain metastasesMedian durationSafety outcomesPrimary analysisFinal overall survival analysisHuman epidermal growth factor receptor 2 positive metastatic breast cancerPositive metastatic breast cancerMeaningful survival benefitMedian overall survivalPlacebo-controlled trialOverall study populationOverall survival analysisFinal OSMetastatic HER2Placebo combinationAdverse eventsLast patientPrespecified subgroupsCorrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; 32: 983-993
Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, Rugo HS, Schneeweiss A, Winer EP, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Patel S, Chui SY, Schmid P. Corrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; 32: 983-993. Annals Of Oncology 2021, 32: 1650. PMID: 34740469, DOI: 10.1016/j.annonc.2021.10.002.Peer-Reviewed Original ResearchCorrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable locally advanced or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; volume 32: 983–993
Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, Rugo HS, Schneeweiss A, Winer EP, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Patel S, Chui SY, Schmid P. Corrigendum to ‘First-line atezolizumab plus nab-paclitaxel for unresectable locally advanced or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis’ Annals of Oncology 2021; volume 32: 983–993. Annals Of Oncology 2021, 32: 1308. PMID: 34353668, DOI: 10.1016/j.annonc.2021.07.013.Peer-Reviewed Original ResearchFirst-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis
Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, Rugo HS, Schneeweiss A, Winer EP, Patel S, Henschel V, Swat A, Kaul M, Molinero L, Patel S, Chui SY, Schmid P. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis. Annals Of Oncology 2021, 32: 983-993. PMID: 34272041, DOI: 10.1016/j.annonc.2021.05.355.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerPD-L1 (+) immune cellsTriple-negative breast cancerOverall survivalImmune cellsITT populationOS benefitNab-paclitaxelBreast cancerFinal overall survival analysisTumor-infiltrating immune cellsFinal overall survivalFirst-line atezolizumabMedian overall survivalFirst-line treatmentProgression-free survivalOverall survival analysisPrespecified analysis planMedian OSCoprimary endpointsAdverse eventsPositive patientsUnacceptable toxicitySafety outcomesToxicity profile
2019
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA, Investigators I. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology 2019, 21: 44-59. PMID: 31786121, DOI: 10.1016/s1470-2045(19)30689-8.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPaclitaxelPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateTriple Negative Breast NeoplasmsYoung AdultConceptsMetastatic triple-negative breast cancerInterim overall survival analysisTriple-negative breast cancerOverall survival analysisTreatment-related deathsMedian overall survivalNab-paclitaxelPhase 3 trialOverall survivalTreat populationBreast cancerSurvival analysisAtezolizumab groupPlacebo groupInterim analysisTreatment groupsEastern Cooperative Oncology Group performance statusDay 1Interactive voice-web response systemInvestigator-assessed progression-free survivalMeaningful overall survival benefitNew treatment-related deathsProgression-free survival resultsSolid Tumors version 1.1Tumor-infiltrating immune cells